UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039209 |
|---|---|
| Receipt number | R000044712 |
| Scientific Title | Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer |
| Date of disclosure of the study information | 2020/01/21 |
| Last modified on | 2024/01/24 10:44:28 |
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Basic information
Public title
Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Acronym
Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Scientific Title
Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Scientific Title:Acronym
Exploring radiosensitivity predictive factors using body fluid metabolomes for non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Although radiotherapy is effective for treating various forms of lung cancer, radiotherapy-related toxicities of radiation pneumonitis (RP) can be life-threatening. However, predicting RP before radiotherapy is still difficult because patient-related factors are not fully understood. Thus, we investigated saliva metabolites to search for independent patient-related risk factors for predicting future RP.
Basic objectives2
Others
Basic objectives -Others
Evaluation of changes in saliva metabolites associated with radiotherapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We collected patients' saliva metabolites before, 2 weeks after, and 3 months after the start of radiotherapy, and just after the end of treatment. To search for independent patient-related risk factors for predicting future radiation pneumonitis using saliva metabolomes.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Twenty years of age or older; patients histologically diagnosed with non-small cell lung cancer (NSCLC), or diagnosed by the cancer board conference, in case where the histological diagnosis appears risky.
2)Patients suitable for curative radiotherapy
3)No history of thoracic radiotherapy
Key exclusion criteria
1)Patients with active interstitial pneumonia
2)Patients with severe liver cirrhosis, diabetes mellitus or cardiovascular diseases
3) Patients with malignancies other than lung cancer
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sachika |
| Middle name | |
| Last name | Shiraishi |
Organization
Tokyo Medical University
Division name
Department of radiology
Zip code
1600023
Address
6-7-1 Nishi-shinjuku,Shihnjuku-ku,Tokyo
TEL
0333426111
s-nogi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Sachika |
| Middle name | |
| Last name | Shiraishi |
Organization
Toyko Medical University
Division name
Department of radiology
Zip code
1600023
Address
6-7-1 Nishi-shinjuku,Shihnjuku-ku,Tokyo
TEL
0333426111
Homepage URL
s-nogi@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Radiology, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB comittee, Tokyo Medical University
Address
6-7-1 Nishi-shinjuku,Shihnjuku-ku,Tokyo
Tel
0333426111
IRB@tokyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
29
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Registration period is determined to be two years. The follow up period is set to be another 1 year from the end of the radiotherapy.
Management information
Registered date
| 2020 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044712
